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LeprosyPhase 4U-MDTNCT00669643

Uniform Multidrug Therapy Regimen for Leprosy Patients

A Phase 4 study testing PB 6 doses - Rifampicin and Dapsone, PB 6 doses - Rifampicin, Clofazimine and Dapsone and MB 12 doses - Rifampicin, Clofazimine and Dapsone in people with Leprosy, run by University of Brasilia at 2 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this randomized trial is to verify if leprosy patients, despite of their classification, can be treated with the same regimen without compromising patient cure and acceptability of the treatment. Read more about this study

Who is it for?
Ages 6 to 65 years
Conditions the study is for
Leprosy
What is being tested?
PB 6 doses - Rifampicin and Dapsone, PB 6 doses - Rifampicin, Clofazimine and Dapsone and MB 12 doses - Rifampicin, Clofazimine and Dapsone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
859 participants
Where
2 sitesBrazil
Study dates
Feb 2007to 31 Dec 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • All newly diagnosed leprosy cases with characteristic skin lesions, with or without systemic symptoms or confirmed by histopathological study previously untreated PB and MB leprosy patients.
  • Never treated or patient treated more than five years ago

Who cannot join

  • Safety concerns:
  • History of intolerance to one of the medications
  • Lack of suitability for the trial:
  • Absence of leprosy skin lesions
  • Pure neural leprosy (PNL)
  • Patient previously (defaulters and relapse) treated for leprosy less than 5 years ago
Show all 11Show fewer
  • Association with other serious diseases such as HIV/AIDS, Tuberculosis, Malaria, American Cutaneous leishmaniasis, Visceral Leishmaniasis, Lymphoma, Leukaemia, Immunosuppression, etc.
  • Administrative reasons
  • Patients who are not permanent residents of the area or who are unable to come to the clinic every month during their treatment and in the first half year (the intensive follow-up period) after their treatment.
  • Patients who do not give informed consent or are not capable to give informed consent due to mental impairment.
  • Patients with overt signs of AIDS because it is unlikely that we can follow them up for the whole study period. As we will not be testing patients for HIV positivity, HIV-infected leprosy patients can be included in the study.

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites

  • Centro de Referência Nacional Dona Libânia - CDERM

    Fortaleza, Ceará, 60.101-035

  • Centro de Referência Nacional Alfredo da Matta - FUAM

    Manaus, Amazonas, 69.065-130

Other trials in Brazil

About this study

Official title: Independent Study to Establish the Efficacy of the Six Doses Uniform MDT Regimen (U-MDT) for Leprosy Patients

The purpose of this randomized trial is to verify if leprosy patients, despite of their classification, can be treated with the same regimen without compromising patient cure and acceptability of the treatment. At present, patients classified as multibacillary leprosy are treated for 12 months with three drugs, and patients classified as paucibacillary leprosy are treated for 6 months with two drugs. The study is going to test a unified regimen for paucibacillary and multibacillary patients by treating leprosy patients with three drugs for 6 doses.

Read the detailed description

In the past both the treatment of new leprosy patients and the classification criteria for treatment purposes have gone through major changes. At the moment, newly diagnosed leprosy patients are classified into PB and MB based on the number of lesions only. More than 5 lesions leads to a classification as MB patient and treatment for 12 months with MDT composed of three drugs, i.e. rifampicin, dapsone and clofazimine. One to 5 lesions leads to a classification as PB patient and treatment for 6 months with MDT composed of two drugs, i.e. rifampicin and dapsone.

Despite all the favorable data from the point of view of practical application, this therapeutic regimen still presents some constraints, including the lengthy course of treatment. Especially in those situations where leprosy control is integrated into the general health services classification is a problem for the general health worker that has only received one or two days of training in leprosy.

A uniform regimen for leprosy would simplify treatment in the field. Results from control programs and research projects have demonstrated that relapse rates after MDT are extremely low, approximately 0.2% annually among MB cases on the 24-dose regimen. The low relapse rates indicate that there was room to shorten the course of MDT to less than 24 monthly-supervised doses of rifampicin plus self-administered doses of dapsone and clofazimine. Although some papers have suggested that relapse rates after MDT may be significantly higher in MB patients with an initial bacterial index equals or bigger than 3, the present diagnostic universe of leprosy includes few such patients, and the total number of relapses caused by them would account for a minimal percentage of cases in a control program. Since 1998, a 12-month treatment course for MB leprosy is advised by WHO. The main problem when evaluating any new treatment regimen for leprosy, is that there are no good and reliable data available for the current treatment regimen: relapse rates have never been systematically determined and the same holds true for reaction and nerve function impairment rates, the major cause of the nerve damage that leads to handicaps and deformities in leprosy patients.

Currently, WHO is exploring possibilities to introduce a short uniform treatment regimen for all types of leprosy patients called Uniform Multidrug Therapy (U-MDT), as a replacement for the present regular multidrug therapy (R-MDT). This U-MDT would consist of treatment of all patients for 6 months with a regimen consisting of three drugs: rifampicin, dapsone and clofazimine. The efficacy of this U-MDT is currently being studied in an open non-controlled treatment trial. Classification of patients is only done on clinical criteria: no skin smears or other lab tests are included. The diagnosis of relapse will rely on clinical diagnosis only. It will therefore not be possible to identify high-risk groups for relapse, such as highly skin smear positive patients.

The objective of our study is to evaluate both the R-MDT and the U-MDT regimens in a randomised trial in order to:

  1. determine the efficacy of the current R-MDT regimen with regard to relapse rates and acceptability to the patient.
  2. determine the efficacy of the U-MDT regimen with regard to relapse rate and acceptability to the patient.
Conditions
Leprosy
Being tested
PB 6 doses - Rifampicin and Dapsone, PB 6 doses - Rifampicin, Clofazimine and Dapsone, MB 12 doses - Rifampicin, Clofazimine and Dapsone, MB 6 doses - Rifampicin, Clofazimine and Dapsone
Keywords
Leprosy, Communicable Diseases, Skin Diseases, Multidrug Therapy, MDT, Uniform Multidrug Therapy, U-MDT
Medical subject headings
Leprosy, Communicable Diseases, Skin Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PB 6 doses - Rifampicin and DapsoneDrug

    Also called PB 6 doses of 2 drugs

    Adult: 6 doses;

    1 monthly supervised dose: 600 mg Rifampicin + 100 mg Dapsone; 27 days: p/day - 100 mg Dapsone;

    Children: 6 doses;

    1 monthly supervised dose: 450 mg Rifampicin + 50 mg Dapsone; 27 days: p/day - 50 mg Dapsone

  • PB 6 doses - Rifampicin, Clofazimine and DapsoneDrug

    Also called PB 6 doses of 3 drugs

    Adult: 6 doses;

    1 monthly supervised dose: 600 mg Rifampicin + 300 mg Clofazimine + 100 mg Dapsone; 27 days: p/day - 100 mg Dapsone + 50 mg Clofazimine;

    Children: 6 doses;

    1 monthly supervised dose: Rifampicin 450 mg + 150 mg Clofazimine + 50 mg Dapsone; 27 days: p/day - 50 mg Dapsone + 25 mg Clofazimine

  • MB 12 doses - Rifampicin, Clofazimine and DapsoneDrug

    Also called MB 12 doses of 3 drugs

    Adult: 12 doses;

    1 monthly supervised dose: 600 mg Rifampicin + 300 mg Clofazimine + 100 mg Dapsone; 27 days: p/day - 100 mg Dapsone + 50 mg Clofazimine;

    Children: 12 doses;

    1 monthly supervised dose: Rifampicin 450 mg + 150 mg Clofazimine + 50 mg Dapsone; 27 days: p/day - 50 mg Dapsone + 25 mg Clofazimine

  • MB 6 doses - Rifampicin, Clofazimine and DapsoneDrug

    Also called MB 6 doses of 3 drugs

    Adult: 6 doses

    1 monthly supervised dose: 600 mg Rifampicin + 300 mg Clofazimine + 100 mg Dapsone; 27 days: p/day - 100 mg Dapsone + 50 mg Clofazimine

    Children: 6 doses

    1 monthly supervised dose: Rifampicin 450 mg + 150 mg Clofazimine + 50 mg Dapsone; 27 days: p/day - 50 mg Dapsone + 25 mg Clofazimine

Study groups in NCT00669643
Study groupRoleWhat they receive
R-MDT PBActive comparatorR-MDT PB group: standard/regular treatment recommended by WHO - All patients presenting fewer than 6 skin lesions will receive the standard treatment regimen for paucibacillary patients as the intervention; Intervention - PB 6 doses of rifampicin and dapsone
Receives: Drug: PB 6 doses - Rifampicin and Dapsone
U-MDT PBExperimentalU-MDT PB group: a unified treatment for all patients - All patients presenting fewer than 6 lesions (WHO PB) will receive 6 doses of rifampicin, clofazimine and dapsone as the intervention; Intervention - PB 6 doses of rifampicin, clofazimine and dapsone
Receives: Drug: PB 6 doses - Rifampicin, Clofazimine and Dapsone
R-MDT MBExperimentalR-MDT MB group: standard/regular treatment recommended by WHO - All patients presenting 6 skin or more lesions will receive the standard treatment regimen for multibacillary patients as the intervention; Intervention - MB 12 doses of rifampicin, clofazimine and dapsone
Receives: Drug: MB 12 doses - Rifampicin, Clofazimine and Dapsone
U-MDT MBExperimentalU-MDT MB group: a unified treatment for all patients - All patients presenting 6 lesions or more (WHO MB) will receive 6 doses of rifampicin, clofazimine and dapsone as the intervention; Intervention - MB 6 doses of rifampicin, clofazimine and dapsone
Receives: Drug: MB 6 doses - Rifampicin, Clofazimine and Dapsone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relapse

    Measured: 5 years

Secondary outcomes (4)

  1. Type I Reaction - Reversal Reactions

    Measured: 6 years

  2. Type II Reaction - Erythema nodosum leprosum

    Measured: 6 years

  3. Neurological damage

    Measured: 6 years

  4. Neuritis

    Measured: 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2008 (estimated)
  2. Study startFeb 2007
  3. Primary completionSep 2012
  4. Study completion31 Dec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
859 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00669643
Sponsor's protocol ID
CNPq / DECIT 403293/2005-7
Acronym
U-MDT
Status last verified
May 2017
First submitted
24 Apr 2008
Last updated
1 Jun 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: Data sharing was not previously requested to the Ethical Committee. Therefore, if there will be a request for it, new ethical approval must be obtained.

Publications

  • Becx-Bleumink M. Relapses among leprosy patients treated with multidrug therapy: experience in the leprosy control program of the All Africa Leprosy and Rehabilitation Training Center (ALERT) in Ethiopia; practical difficulties with diagnosing relapses; operational procedures and criteria for diagnosing relapses. Int J Lepr Other Mycobact Dis. 1992 Sep;60(3):421-35.

    PubMed 1474281

  • Britton WJ, Lockwood DN. Leprosy. Lancet. 2004 Apr 10;363(9416):1209-19. doi: 10.1016/S0140-6736(04)15952-7.

    PubMed 15081655

  • Buhrer-Sekula S, Smits HL, Gussenhoven GC, van Leeuwen J, Amador S, Fujiwara T, Klatser PR, Oskam L. Simple and fast lateral flow test for classification of leprosy patients and identification of contacts with high risk of developing leprosy. J Clin Microbiol. 2003 May;41(5):1991-5. doi: 10.1128/JCM.41.5.1991-1995.2003.

    PubMed 12734239

  • Dasananjali K, Schreuder PA, Pirayavaraporn C. A study on the effectiveness and safety of the WHO/MDT regimen in the northeast of Thailand; a prospective study, 1984-1996. Int J Lepr Other Mycobact Dis. 1997 Mar;65(1):28-36.

    PubMed 9207751

  • Jamet P, Ji B. Relapse after long-term follow up of multibacillary patients treated by WHO multidrug regimen. Marchoux Chemotherapy Study Group. Int J Lepr Other Mycobact Dis. 1995 Jun;63(2):195-201.

    PubMed 7602214

  • Jesudasan K, Vijayakumaran P, Manimozhi N, Jeyarajan T, Rao PS. Absence of relapse within 4 years among 34 multibacillary patients with high BIs treated for 2 years with MDT. Int J Lepr Other Mycobact Dis. 1996 Jun;64(2):133-5.

    PubMed 8690971

  • Li HY, Hu LF, Wu PW, Luo JS, Liu XM. Fixed-duration multidrug therapy in multibacillary leprosy. Int J Lepr Other Mycobact Dis. 1997 Jun;65(2):230-7.

    PubMed 9251596

  • Li HY, Hu LF, Huang WB, Liu GC, Yuan LC, Jin Z, Li X, Li JL, Yang ZM. Risk of relapse in leprosy after fixed-duration multidrug therapy. Int J Lepr Other Mycobact Dis. 1997 Jun;65(2):238-45.

    PubMed 9251597

  • Lockwood DN, Suneetha S. Leprosy: too complex a disease for a simple elimination paradigm. Bull World Health Organ. 2005 Mar;83(3):230-5. Epub 2005 Mar 16.

    PubMed 15798849

  • Penna GO, Pontes MAA, Talhari S, Goncalves HS, Talhari C, Pessoa AS, Pedroza V, Buhrer-Sekula S, Stefani MMA, Penna MLF. Late relapses in leprosy patients in Brazil: 10-year post-trial of uniform multidrug therapy (U-MDT/CT-BR). Braz J Infect Dis. 2024 Mar-Apr;28(2):103745. doi: 10.1016/j.bjid.2024.103745. Epub 2024 Apr 30.

    PubMed 38697216

  • Hungria EM, Buhrer-Sekula S, Oliveira RM, Aderaldo LC, Pontes MAA, Cruz R, de Goncalves HS, Penna MLF, Penna GO, Stefani MMA. Mycobacterium leprae-Specific Antibodies in Multibacillary Leprosy Patients Decrease During and After Treatment With Either the Regular 12 Doses Multidrug Therapy (MDT) or the Uniform 6 Doses MDT. Front Immunol. 2018 May 14;9:915. doi: 10.3389/fimmu.2018.00915. eCollection 2018.

    PubMed 29867930

  • Penna GO, Buhrer-Sekula S, Kerr LRS, Stefani MMA, Rodrigues LC, de Araujo MG, Ramos AMC, de Andrade ARC, Costa MB, Rosa PS, Goncalves HS, Cruz R, Barreto ML, Pontes MAA, Penna MLF. Uniform multidrug therapy for leprosy patients in Brazil (U-MDT/CT-BR): Results of an open label, randomized and controlled clinical trial, among multibacillary patients. PLoS Negl Trop Dis. 2017 Jul 13;11(7):e0005725. doi: 10.1371/journal.pntd.0005725. eCollection 2017 Jul.

    PubMed 28704363

  • Hungria EM, Buhrer-Sekula S, de Oliveira RM, Aderaldo LC, Pontes AA, Cruz R, Goncalves HS, Penna ML, Penna GO, Stefani MM. Leprosy reactions: The predictive value of Mycobacterium leprae-specific serology evaluated in a Brazilian cohort of leprosy patients (U-MDT/CT-BR). PLoS Negl Trop Dis. 2017 Feb 21;11(2):e0005396. doi: 10.1371/journal.pntd.0005396. eCollection 2017 Feb.

    PubMed 28222139

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing PB 6 doses - Rifampicin and Dapsone, PB 6 doses - Rifampicin, Clofazimine and Dapsone and MB 12 doses - Rifampicin, Clofazimine and Dapsone in people with Leprosy, run by University of Brasilia at 2 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relapse (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00669643, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2017.

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